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The schema for Version 2.0 of the ODM can be found at https://github.com/cdisc-org/DataExchange-ODM. The final version of this specification will be posted at https://www.cdisc.org/standards/data-exchange/odm.

Example of prolog and top-level ODM v2.0 XML element:

<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    ODMVersion="2.0"
    FileOID="000-00-0000"
    FileType="Transactional"
    Description="Sample ItemData Extension"
    AsOfDateTime="2022-06-04T07:57:00"
    CreationDateTime="2022-06-06T10:30:00">

The semantic constraints are expressed throughout the rest of this document.

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1. The ODM file must be a well-formed JSON file. See the ECMA-404 standard for details.
2. The ODM file must satisfy the rules about element nesting and the formats of values defined in the ODM standard.
3. The root object corresponds to the ODM element.
4. The ODMVersion attribute of the root object must be set to "2.0".

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1. .

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{
    "clinicalData": {
        "studyOID": "cdisc.com/CDISCPILOT01",
        "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7",
        "itemGroupData": {
            "IG.DM": {
                "records": 18,
                "name": "DM",
                "label": "Demographics",
                "items": [ ...
                ],
                "itemData": [ ...
                ]
            }
        }
    }
}